This invention relates to a cannula or catheter device that is capable of multi-access and multidirectional flow for use in providing total cardiopulmonary bypass support and isolation of the heart during traditional open chest surgery as well as minimally invasive surgical techniques.
This invention relates to improvements in devices used for cardiovascular, pulmonary and neurosurgical procedures where the patient is placed on cardiopulmonary bypass. More specifically, this invention relates to an introducer and perfusion cannula device that provides a single insertion site where multiple catheters may be inserted in order to provide multidirectional flow and access.
Although there are existing introducers or perfusion cannulas that offer access for introduction of catheters or cannulas into a patient""s aorta or other vascular access sites, none offer the benefits of the current invention. U.S. Pat. No. 5,478,309 (Sweezer) describes an aortic perfusion cannula offering access for a catheter device through an aortic insertion site. However, the device described by Sweezer does not provide access for multiple catheter devices, nor does it provide multidirectional flow. In addition, U.S. Pat. No. 5,254,097 (Schock) describes a device that allows for insertion of a catheter device, e.g. an intra-aortic balloon pump, through a femoral artery perfusion cannula, however this device does not provide access for multiple catheter devices, nor does it provide multidirectional flow. By providing access for multiple catheter devices and multidirectional flow through a single insertion site, the present invention facilitates segmentation of a patient""s aorta for selective perfusion and it allows repositioning and exchanging of catheter devices without additional trauma to the insertion site.
Furthermore, the present invention offers the benefit of a sealing mechanism that is capable preventing blood flow outside of a vessel after insertion. By providing a sealing mechanism of this type, a surgeon is able to secure the cannula in a fixed position after insertion without having to be concerned with cannula movement or blood loss through the insertion site. In addition, the sealing device allows insertion of multiple catheter devices and repositioning or exchanging of catheter devices without additional trauma to the insertion site.
In a further aspect, the invention provides for a flow control regulator that may take the form of an occlusion balloon. By incorporating such a device into the present cannula, segmentation of the aorta is possible and because of the position of the occlusion balloon on the cannula shaft multidirectional flow is still accomplished.
The present invention provides a multi-access cannula for use in a variety of surgical procedures, particularly for use in the course of performing conventional open-chest and peripheral access cardiopulmonary bypass (CPB). In such procedures, the multi-access cannula facilitates insertion of multiple cannulas or catheter devices through a single puncture site. At the appropriate depth of insertion, a closure seal may be engaged at the point of entry to secure the positioning of the cannula and prevent leakage of blood from the incision. At this point, the cannula provides a multiplicity of procedural options for the surgeon. For example, when approaching through the ascending aorta, the multi-access cannula enables the simultaneous passage of various fluids, catheters and/or instruments in opposing directions within the lumen of the aortic arch. One possible direction, upstream, provides access to the aortic root, coronary arteries, aortic valve and left ventricle. Through this cannula access, cardioplegia delivery and venting may be achieved. Another possible direction, downstream, provides access to the arch vessels and descending aorta. Through this cannula access, direct perfusion of the arch and corporeal circulation may be achieved or numerous devices may be inserted, such as prioritized perfusion catheters or Intra-Aortic Balloon Pumps. In addition, the present invention may include intra-luminal flow regulators to eliminate the need for cross-clamping of the aorta. Such flow regulators may be positioned between the directional access paths to provide compartmentalization of the aorta. The utilization of any of the aspects of the multi-access cannula are independent. For example, the surgeon may initiate one procedure and decide whether to insert another device at a future time. Thus, the present invention increases operational flexibility, reduces the level of trauma and minimizes the crowding of the surgical field due to its multi-access functionality and distinct sealing capabilities.